Vicks DayQuil and Vicks NyQuil Cold and Flu — v11

Vicks DayQuil and Vicks NyQuil Cold and Flu

7 Views

Version

v11

Effective date

October 1, 2025

Original packager

Yes

Sections captured

19

Identifiers

Document ID
401e4e5d-78c9-5cc3-e063-6294a90a39e5
Set ID
416c6674-e4aa-6375-e054-00144ff8d46c
Application numbers
M012
Product NDCs
37000-033
Package NDCs
37000-033-24, 69423-788-12, 69423-789-12
Original packager NDCs

Names & Manufacturers

Brand names
Vicks DayQuil and Vicks NyQuil Cold and Flu
Generic names
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE
Manufacturer names
The Procter & Gamble Manufacturing Company
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
1043400, 1113705, 2637726
UNII
UPC

Structured Label Sections

Active Ingredient (2)

Sequence 1

Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg Purpose Pain reliever/ fever reducer Cough suppressant Antihistamine

Sequence 2

Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg Purpose Pain reliever/Fever reducer Cough suppressant Nasal decongestant
Ask Doctor (4)

Sequence 1

Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland

Sequence 2

Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet

Sequence 3

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Sequence 4

Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion or cough get worse or last more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
Ask Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin
Do Not Use (2)

Sequence 1

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Sequence 2

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Dosage And Administration (2)

Sequence 1

Directions take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Sequence 2

Directions take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use
Dosage And Administration Table (2)

Sequence 1

adults & children 12 yrs & over30 mL every 6 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Sequence 2

adults & children 12 yrs & over30 mL every 4 hrs
children 6 to under 12 yrs15 mL every 4 hrs
children 4 to under 6 yrsask a doctor
children under 4 yrsdo not use
Inactive Ingredient (2)

Sequence 1

Inactive ingredients alcohol, citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium,, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Sequence 2

Inactive ingredients citric acid, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum
Indications And Usage (2)

Sequence 1

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose and sneezing

Sequence 2

Uses temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever
Keep Out Of Reach Of Children (2)

Sequence 1

Keep out of reach of children.

Sequence 2

Keep out of reach of children.
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL - Convenience Pack POWERFUL RELIEF Day & Night Pack VICKS ® DayQuil ™ COLD & FLU Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Headache, Fever, Sore Throat, Minor Aches & Pains Nasal Congestion, Sinus Pressure Cough NyQuil ™ COLD & FLU Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr Headache, Fever, Sore Throat, Minor Aches & Pains Sneezing, Runny Nose Cough Nighttime Relief Alcohol 10% 2 BOTTLES – 1 DAYQUIL/1 NYQUIL 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 mL) 033
Pregnancy Or Breast Feeding (2)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.

Sequence 2

If pregnant or breast-feeding, ask a health professional before use.
Purpose (2)

Sequence 1

Purpose Pain reliever/ fever reducer Cough suppressant Antihistamine

Sequence 2

Purpose Pain reliever/Fever reducer Cough suppressant Nasal decongestant
Questions (2)

Sequence 1

Questions? 1-800-362-1683

Sequence 2

Questions? 1-800-362-1683
Spl Product Data Elements (1)

Sequence 1

Vicks DayQuil and Vicks NyQuil Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Doxylamine Succinate VICKS DAYQUIL COLD AND FLU Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE SORBITOL SUCRALOSE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE VICKS NYQUIL COLD AND FLU Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate DOXYLAMINE SUCCINATE DOXYLAMINE ALCOHOL CITRIC ACID MONOHYDRATE FD&C GREEN NO. 3 D&C YELLOW NO. 10 PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE XANTHAN GUM FD&C YELLOW NO. 6 ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN
Spl Unclassified Section (4)

Sequence 1

NyQuil Cold & Flu Drug Facts

Sequence 2

Dist. by Procter & Gamble, Cincinnati OH 45202

Sequence 3

DayQuil Cold & Flu Drug Facts

Sequence 4

TAMPER EVIDENT: Do not use if printer shrinkband on bottle is broken or missing.
Stop Use (1)

Sequence 1

Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.
Storage And Handling (2)

Sequence 1

Other information each 30 mL contains: sodium 23 mg store at no greater than 25°C and do not refrigerateand do not refrigerate

Sequence 2

Other information each 15 mL contains : sodium 46 mg store at no greater than 25°C and do not refrigerate.
Warnings (2)

Sequence 1

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddening Blisters Rash If a skin reaction occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Sequence 2

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adults take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product child take more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddening Blisters Rash If a skin reaction occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion or cough get worse or last more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
When Using (2)

Sequence 1

When using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness

Sequence 2

When using this product, do not use more than directed.

OpenFDA raw payload

{'application_number': ['M012'],
 'brand_name': ['Vicks DayQuil and Vicks NyQuil Cold and Flu'],
 'generic_name': ['ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE '
                  'HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE'],
 'is_original_packager': [True],
 'manufacturer_name': ['The Procter & Gamble Manufacturing Company'],
 'package_ndc': ['37000-033-24', '69423-788-12', '69423-789-12'],
 'product_ndc': ['37000-033'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['1043400', '1113705', '2637726'],
 'spl_id': ['401e4e5d-78c9-5cc3-e063-6294a90a39e5'],
 'spl_set_id': ['416c6674-e4aa-6375-e054-00144ff8d46c']}